Cenobamate in the Intensive Care Unit (CENOBITE)

Mass General Brigham

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Epilepsy

Neurologic Disorder

Treatments

Drug: Cenobamate

Study type

Interventional

Funder types

Other

Identifiers

NCT06352723

2024P000856

Details and patient eligibility

About

The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH.

Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18-70.
Undergoing EEG monitoring.
Acute frequent seizures (>1/hour) or status epilepticus (>5 min of consecutive seizures, or seizure burden >20% within past 1 hour).
Adjunctive conventional antiseizure medication indicated.

Exclusion criteria

History of medication-related rash.
On medication or device affecting enteral absorption (e.g., phenobarbital, pentobarbital).
Counterindication to cenobamate as described in the prescribing information.